Analyst, Quality Assurance (Biotech)
Sarasota, FL (East Coast)
Akron Biotech is continuing to transform and further its rapidly growing capabilities and is now seeking highly motivated professionals to join our expanding team. This is an exciting opportunity to play a critical role within our organization that is driving advanced therapy development and commercialization with high quality industrial scale solutions. We manufacture and distribute components and raw materials for cell therapy discovery, development, and commercialization to meet industry needs worldwide. We offer an array of highly competitive benefits and perks to our valued associates.
- Assist management in implementation and maintenance of a Quality Assurance Program/ Quality Management System compliance with applicable regulations and industry standards (e.g. FDA 21CFR, QSR, cGMP, GLP, ISO13485).
- Ensure compliance with Company’s policies and QMS requirements.
- Maintain Quality Manual and related documentation (i.e. Standard Operating Procedures) current with applicable regulations and industry standards.
- Implement tracking of Key Performance Indicators. Monitor and report KPI’s trend to management. Identify action to correct adverse trend within areas of responsibilities.
- Initiate and review deviations/non-conformances. Leads, supports, and collaborates with other functions for timely investigation, identification, and implementation of best-in-class quality manufacturing practices.
- Provide support to regulatory inspections and customer’s audits.
- Assist in preparing responses to regulatory and accrediting agency compliance’s inspection and audit reports.
- Supports the maintenance of training records.
- Assists with document review process and supports timely review/approval of documents.
- Review and approve incoming raw materials and finished product.
- Review incoming new equipment and equipment calibration records.
- Performs other duties as assigned.
- BS or MS in Biology, Business or other related major.
- Minimum of 3 years working in FDA regulated industries within a QA role.
- Experience in Manufacturing or Quality organizations supporting production, testing, release and distribution of cGMP products.
- Strong team player maintaining with good communication skills across all levels within the organization.
- Excellent English writing skills and able to convey ideas in a clear and concise way.
- Results oriented - Highly motivated and able to work independently to achieve objectives.
- Shows a high degree of self-driven initiative and innovation.
- Strong computer skills – working knowledge of software functions (e.g. MS Word, Excel and
- Power Point) and ability to work well with Internet Explorer and Outlook.
- Knowledge of Quality Assurance principles in a FDA Regulated environment.
- Working knowledge of FDA QSR regulations and ISO standards.